First Patient First Visit definition

First Patient First Visit means the completion, in accordance with applicable study protocol and regulations, of a first study visit by a human subject in a clinical trial.
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First Patient First Visit means the administration of the first dose of a Compound, Analogue or Drug Product to the first patient at his or her first visit in a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, as applicable.
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First Patient First Visit and “FPFV” mean the first visit at which data (e.g., medical history) is collected from the first study subject to determine eligibility to participate in a given clinical study.
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Examples of First Patient First Visit in a sentence

  • In order to comply with very basic quality control requirements every study sponsored by the Trust should include monitoring activities on Level 1, i.e. verification of:▪ Study status▪ Recruitment rates▪ Time taken to First Patient First Visit (FPFV)▪ Recruitment to Time and TargetThe Level 1 quality control activities shall be documented electronically as part of the recruitment submission.

  • In the event that Novartis exercises the Buyback Right with respect to a Compound prior to or upon the First Patient First Visit in a Phase II Clinical Trial for such Compound, then Novartis or its Affiliates shall pay to Evotec (i) [***] (ii) [***] (if any) that would have been paid with respect to such Compound pursuant to Section 5.2 but for Evotec’s exercise of the Development Option for such Compound, each within sixty (60) calendar days after the receipt by Novartis of Evotec’s Invoice for the same.

  • In the event that Novartis exercises the Buyback Right with respect to a Compound after the First Patient First Visit in a Phase II Clinical Trial for such Compound, then Novartis or its Affiliates shall pay to Evotec (i) [***] (ii) [***] (if any) that would have been paid with respect to such Compound pursuant to Section 5.2 but for Evotec’s exercise of the Development Option for such Compound, each within sixty (60) calendar days after the receipt by Novartis of Evotec’s Invoice for the same.

  • Third, in order to precisely estimate the relationship between the mediator variable (i.e., trust) and the dependent variable (i.e., HVPL benefit-risk perceptions), we ran the regression while adding the trust variable to the right side of the regression equation used for the first step of the analysis.

  • Upon grant, 423,266 options vested immediately and 50,000 options will vest upon First Patient First Visit for the Phase 2b lupus trial.

  • These milestones include key stages of the Project such as Study Initiation, Site Activation, First Patient First Visit (FPFV), and Final Study Report Submission to the FDA.

  • The study start date is the date on which the first clinical study site is opened for recruitment of participants.The first act of recruitment is the First Patient First Visit for whole study.The sponsor designee reserves the right to close the study site or terminate the study at any time for any reason at the sole discretion of the sponsor.

  • The DRIVE website (www.researchreadydrive.co.uk) provides an overview of the project and provides a document repository for downloadable tools including ‘Top Tips’ for Site Initiation Visits and achieving First Patient First Visit metrics, a recruitment planning and capacity and capability assessment tools.

  • The interim analysis in 2016 was based on cumulative data collected from the point of First Patient First Visit (FPFV) in January 2000 until the last subject year 10 follow-up visit (Last Patient Last Visit (LPLV) in February 2016.

  • The Information Officer will then take over responsibility for data maintenance of that study on EDGE which includes gathering First Patient First Visit (FPFV) and recruitment to time and target information.

Related to First Patient First Visit

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • MEDICAL STAFF LEADER means any Medical Staff Officer, department chair, section chief, and committee chair.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Non-Administrator Ambulatory Surgical Facility means an Ambulatory Surgical Facility which does not meet the definition of an Administrator Ambulatory Surgical Facility.

  • veterinary surgeon means a veterinary surgeon within the meaning of the Veterinary Surgeons Act 1936.

  • LOCKHEED XXXXXX Procurement Representative means a person authorized by LOCKHEED XXXXXX'x cognizant procurement organization to administer and/or execute this Contract.

  • Assisted outpatient treatment or "AOT" means the categories of outpatient services ordered by the court under section 468 or 469a. Assisted outpatient treatment may include a case management plan and case management services to provide care coordination under the supervision of a psychiatrist and developed in accordance with person-centered planning under section 712. Assisted outpatient treatment may also include 1 or more of the following categories of services: medication; periodic blood tests or urinalysis to determine compliance with prescribed medications; individual or group therapy; day or partial day programming activities; vocational, educational, or self-help training or activities; assertive community treatment team services; alcohol or substance use disorder treatment and counseling and periodic tests for the presence of alcohol or illegal drugs for an individual with a history of alcohol abuse or substance use disorder; supervision of living arrangements; and any other services within a local or unified services plan developed under this act that are prescribed to treat the individual's mental illness and to assist the individual in living and functioning in the community or to attempt to prevent a relapse or deterioration that may reasonably be predicted to result in suicide, the need for hospitalization, or serious violent behavior. The medical review and direction included in an assisted outpatient treatment plan shall be provided under the supervision of a psychiatrist.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Medical Specialist means any medical practitioner who is vocationally registered by the Medical Council under the Health Practitioners Competence Assurance Act 2003 in one of the approved branches of medicine and who is employed in either that branch of medicine or in a similar capacity with minimal oversight.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Secondary Suite means an accessory dwelling unit that is attached to a single-family residential building on a lot in a zone that permits a single family residential building; (Bylaw 8036 & 8360)

  • Ambulatory surgical facility means a facility that:

  • Secondary dose monitoring system means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

  • Medical marijuana dispensary means the location from which a registered cardholder may obtain

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Mobile crisis outreach team means a crisis intervention service for minors or families of minors experiencing behavioral health or psychiatric emergencies.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Medical Child Support Order means any judgment, decree or order (including approval of a domestic relations settlement agreement) issued by a court of competent jurisdiction that:

  • Outpatient treatment means mental health or substance abuse treatment services rendered to a

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Emergency Medical Event means an event wherein an Insured Person’s medical condition and situation are such that, in the opinion of the Company’s affiliate or authorized vendor and the Insured Person’s treating physician, the Insured Person requires urgent medical attention without which there would be a significant risk of death, or serious impairment and adequate medical treatment is not available at the Insured Person’s initial medical facility.